Trials / Not Yet Recruiting
Not Yet RecruitingNCT07373561
Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors
Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 800 (estimated)
- Sponsor
- Zealand University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study aims to estimate the prevalence of post-intensive care syndrome (PICS) 12 months after ICU admission among adult ICU survivors in Denmark and to describe how this prevalence is distributed across the physical, cognitive, and mental health domains. By conducting follow-up assessments at 3, 6, and 12 months post-discharge, the study further seeks to determine the prevalence of PICS at each time point, characterise its temporal trajectory, and explore patients' symptom burden over time. Research question * What is the prevalence of PICS and its specific components (physical, cognitive, and mental health domains) among ICU survivors 12 months after ICU admission? * How do the components of PICS evolve during the follow-up period (trajectory)? * What risk factors are associated with the development of PICS in ICU survivors? * Are there differences in PICS prevalence based on demographic or clinical characteristics (e.g., age, comorbidities, ICU length of stay)? The hypothesis is that the prevalence of post-intensive care syndrome (PICS) in a Danish cohort of adult ICU survivors at 12 months will be approximately one third, defined as impairment in at least one of the three PICS domains (physical, cognitive, or mental health), measured using validated instruments with pre-specified cut-offs.
Conditions
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-06-30
- Completion
- 2028-09-30
- First posted
- 2026-01-28
- Last updated
- 2026-01-30
Source: ClinicalTrials.gov record NCT07373561. Inclusion in this directory is not an endorsement.